NEW YORK (GenomeWeb) – Sunnyvale, California-based InSilixa has received funding to develop a point-of-care rapid molecular diagnostic assay for oral human papillomavirus detection, the company announced today.
The $224,764 Phase I Small Business Innovation Research grant was awarded by the National Institutes of Health.
The assay is "a potential new tool to screen oral specimens such as saliva for cancer-causing HPV types and to risk stratify those persons found to be positive,” Gary Schoolnik, chief medical officer of InSilixa, said in a statement.
The diagnostic will be based on InSilixa's proprietary complementary metal-oxide semiconductor, or CMOS, biochip. The chip enables rapid detection and genotyping of pathogens in clinical samples, as well as simultaneous drug-resistance profiling, using highly-multiplexed targeted DNA sequencing, according to the firm.
"The unique cost and performance of InSilixa’s CMOS biochips make it possible to create viable products in markets that historically have not been addressable by DNA sequencing technologies," Arjang Hassibi, InSilixa's CEO, noted.
The HPV assay will also be based on a qPCR method developed by co-investigators at the University of North Carolina, according to the grant abstract.
That method is a multiplex assay that can detect, identify, and quantify HPV 6, 11, 16 and 18 L1 gene type-specific sequences, as well as HPV E1 gene consensus sequences common to all HPV types.
The firm said its first generation of products are focused on near-patient and point-of-care infectious disease molecular diagnostics. In addition to the HPV and TB assays, this includes rapid detection of multi-drug resistant bacteria in intensive care units, analysis of seasonal respiratory infection outbreaks, and quantification and genotyping of HIV in blood samples.